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FDA Ortho Evra Labeling Revision

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Ortho Evra Lawsuit: Frequently Asked Questions Regarding the FDA Ortho Evra Labeling Revision
Ortho Evra (norelgestromin/ethinyl estradiol)

A notice to all Ortho Evra Birth Control Patch users:
It was discovered that the Ortho Evra patch could lead to a variety of harmful side effects, including some extremely dangerous ones like heart attack, stroke, deep vein thrombosis or pulmonary embolism.

If you or someone you love has suffered after using Ortho Evra, you may be entitled to a lawsuit. All you need to do is fill out a form and you will receive a free case evaluation from Weitz & Luxenberg.


1. What is FDA announcing today?

FDA is announcing a revision to the label for the drug Ortho Evra, the only skin patch approved for birth control. This change includes a new bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen, a commonly prescribed dose. Higher levels of estrogen may put some women at increased risk for getting blood clots. When thinking about prescribing or using Ortho Evra, healthcare professionals and women need to balance the increased exposure to estrogen against the chance of pregnancy if a birth control pill is not taken daily.

2. Why is the FDA making this announcement?

A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. There are also high dose estrogen pills on the market, such as the 50 microgram birth control pills, and some women need these. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.

3. How does the increase in exposure of estrogen affect me when taking Ortho Evra?

In general, a woman may be at higher risk for getting side effects if she takes higher doses of estrogen. However, it is not known if a woman using the Ortho Evra patch is at higher risk for serious side effects than if she is using a typical birth control pill. Women should discuss with their health care professional whether the Ortho Evra patch is a good method of contraception for them.

4. Can a woman decrease the amount of estrogen from the Ortho Evra patch by cutting the patch and applying only a part of the patch?

No. The patch should not be cut. If cut or altered, Ortho Evra will not protect against pregnancy.

5. If a woman wants to change from the Ortho Evra patch to a birth control pill, what should she do?

Talk to her health care professional. The health care professional will help her make this change.

6. Where can I find more information on this?

If you have further questions regarding any medications, please contact the Center for Drug’s Division of Drug Information at: 888-INFO-FDA (888-463-6332), or email us at: druginfo@cder.fda.gov.



Act Now! It is essential that you inquire about your Ortho Eva lawsuit as soon as possible. Your individual state's law may limit your time to bring a legal claim to protect your rights. Your legal review is free and there is no commitment. You case will be evaluated immediately, so get started on your claim today!

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Please complete the following questionnaire:

Name
Email
Phone Number
Best time to call
Did you use the Ortho Evra Birth Control Patch?yes
no
How long have you used the patch?
Have you experienced any of the following? blood clot
heart attack
stroke
pulmonary embolism
other
internal blood clot
menstrual clotting
If other, please describe
Do you smoke?yes
no
Additional comments/questions:


see also:

FDA Ortho Evra Labeling Revision Ortho Evra Lawsuit Research: FDA Ortho Evra Labeling Revision
Ortho Evra FDA Press Release: FDA Ortho Evra Labeling Revision

FDA Press Release Ortho Evra: FDA Press Release- Labeling Warning
Ortho Evra FDA Press Release: Labeling from Ortho Evra Lawyers/Attorneys

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